ENVISION BLOWER KIT
Received Oct 22, 2025 · Event occurred Oct 20, 2025
Report 1824206-2025-01857 · MDR key 23360647
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P136026Catalog number
P136026
Lot number
N/A
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BAXTER RECEIVED A REPORT STATING THAT ENVISION BLOWER KIT POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL, EXAMINE THE POWER CORD AND ITS PLUG FOR DAMAGE. EXAMINE THE LENGTH OF THE POWER CORD FOR CUTS AND ABRASIONS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND ATTACH THE ANALYZER TO THE EXPOSED METAL CHASSIS GROUND TEST POINT TO MAKE SURE THE GROUND RESISTANCE IS NO MORE THAN 200 MILLIOHMS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND MAKE SURE THE LEAKAGE CURRENT IS NO MORE THAN 300 MICROAMPS IN NORMAL CONDITION (NC). REPLACE AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTIVE MAINTENANCE ON THIS BED ON SEPTEMBER 18, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.